Study of MEDI-573 plus standard endocrine therapy for women with hormone-sensitive metastatic breast cancer
Study identifier:CD-ON-MEDI-573-1030
ClinicalTrials.gov identifier:NCT01446159
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1b/2 Randomized Study of MEDI-573 in Combination with an Aromatase Inhibitor (AI) Versus AI Alone in Women with Metastatic Breast Cancer (MBC)
Medical condition
Hormone-sensitive, HER-2 negative metastatic breast cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
MEDI-573, Aromatase Inhibitor
Sex
Female
Actual Enrollment
188
Study type
Interventional
Age
18 Years - 99 Years
Date
Study Start Date: 13 Jun 2011
Primary Completion Date: 28 Jun 2019
Study Completion Date: 28 Jun 2019
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 May 2020 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEDI-573 10 mg/kg + AI Participants who will be enrolled in Phase 1b Cohort A of the study will receive intravenous infusion of MEDI-573 10 mg/kg on Day 1 of each 21-day cycle and AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: MEDI-573 Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
| Experimental: MEDI-573 30 mg/kg + AI Participants who will be enrolled in Phase 1b Cohort B of the study will receive intravenous infusion of MEDI-573 30 mg/kg on Day 1 of each 21-day cycle and AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: MEDI-573 Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
| Experimental: MEDI-573 45 mg/kg + AI Participants who will be enrolled in Phase 1b Cohort C and Phase 2 Arm 1 of the study will receive intravenous infusion of MEDI-573 45 mg/kg on Day 1 of each 21-day cycle and AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: MEDI-573 Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
| Experimental: Aromatase Inhibitor Participants who will be enrolled in Phase 2 Arm 2 of the study will receive oral AI of the investigator’s choice (letrozole, anastrozole, or exemestane) orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. | Drug: Aromatase Inhibitor Aromatase inhibitor of the investigator’s choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons. |
Contacts
Investigators
Principal Investigator
MedImmune LLC
MedImmune, LLC
